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Alzheimer DiseasePhase 1NCT06127368

Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers

A Phase 1 study testing GB-5001A, GB-5001D and Oral cohort in people with Alzheimer Disease, run by G2GBio, Inc. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM and SC depot in healthy male Adults. And, It is to evaluate pharmacokinetic characteristics of GB-5001 (donepezil) IM and SC single dose injection vs. active comparator. Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
GB-5001A, GB-5001D and Oral cohort
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSouth Korea
Study dates
3 Jan 2024to 14 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit
  • Subject with a body weight of 55 kg or more and a body mass index (BMI) equal to or greater than 18.5 kg/m² but less than 30 kg/m²
  • Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination
  • Subject who has been deemed suitable based on screening test results assessed by the principal investigator
  • Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures

Who cannot join

  • Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial.
  • Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions.
  • Rhabdomyolysis
  • Seizure, Epilepsy, Fainting
  • peptic ulcer or gastrointestinal hemorrhage
  • Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion
Show all 15Show fewer
  • Severe physical/organ abnormalities
  • Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus
  • Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial.
  • Medications, including antidepressants, that can induce Rhabdomyolysis
  • Medications with a risk of ulcer development.
  • Potent inhibitors of cytochrome P450 (CYP) enzymes
  • Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors
  • Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access
  • Subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or Subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period

Trial locations and contacts

1 site in 1 country.

Jimin Hwang contact

82-2-400-2681

clinicalstudy@g2gbio.com

Sangsub Lee contact

82-2-400-2694

clinicalstudy@g2gbio.com

South Korea1 site, 1 recruiting

  • Chungnam National University Hospital

    Daejeon

    Hong

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-label, Active-controlled, Parallel and Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers

This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM and SC depot in healthy male Adults. And, It is to evaluate pharmacokinetic characteristics of GB-5001 (donepezil) IM and SC single dose injection vs. active comparator.

Being tested
GB-5001A, GB-5001D, Oral cohort
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB-5001ADrug

    Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.

  • GB-5001DDrug

    Depending on the cohort, volume will be varied to administer.

  • Oral cohortDrug

    Single dose of Aricept tablet.

Study groups in NCT06127368
Study groupRoleWhat they receive
GB-5001AExperimentalGB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.
Receives: Drug: GB-5001A
GB-5001DExperimentalGB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.
Receives: Drug: GB-5001D
Oral cohortActive comparatorAricept® tablet. The cohort is determined through random allocation.
Receives: Drug: Oral cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Number of participants with adverse events

    Measured: Part A: Cohort A, B : Upto Day 106 / Cohort C : Upto Day 71 / Cohort D : Upto Day 18, Part B: Cohort E, F, M : Upto Day 18 or Day 106

  2. Clinical Laboratory tests

    Incidence of abnormal clinically significant clinical laboratory test results. (Hematology, Blood Chemistry Test, Urine Test, Blood Coagulation Test, Serum Test and Urine Drug Screening Test.) /Day 1 to Day

    Measured: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99

  3. Vital Signs

    Incidence of abnormal clinically significant vital signs.(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature)

    Measured: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99

  4. Physical examination

    Incidence of abnormal clinically significant Physical examination. (This includes an evaluation of the overall appearance and a review of the physical organ systems through questioning, visual inspection, and palpation.)

    Measured: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99

  5. Electrocardiograms

    Incidence of abnormal clinically significant ECG results (Ventricular rate (beats/min), PR interval (msec), QRS (msec), QT (msec), QTc (msec)

    Measured: Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99

Secondary outcomes (9)

  1. Pharmacokinetics (Cmax)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  2. Pharmacokinetics (Tmax)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  3. Pharmacokinetics (Tlag)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  4. Pharmacokinetics (AUCinf)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  5. Pharmacokinetics (AUClast)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  6. Pharmacokinetics (AUC 0-762)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  7. Pharmacokinetics (CL/F)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  8. Pharmacokinetics (Vd/F)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

  9. Pharmacokinetics (t1/2)

    Measured: Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start3 Jan 2024 (estimated)
  3. Primary completion17 Sep 2024 (estimated)
  4. Study completion14 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
sequential
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127368
Sponsor's protocol ID
GB5001A101
Status last verified
Nov 2023
First submitted
7 Nov 2023
Last updated
22 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GB-5001A, GB-5001D and Oral cohort in people with Alzheimer Disease, run by G2GBio, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jimin Hwang (82-2-400-2681, clinicalstudy@g2gbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Part A: Cohort A, B : Upto Day 106 / Cohort C : Upto Day 71 / Cohort D : Upto Day 18, Part B: Cohort E, F, M : Upto Day 18 or Day 106). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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